Medical research involving human subjects, human material or laboratory animals has to be carried out according to national law and regulations. Dedicated ethical committees review research protocols to ensure human and animal safety, and research quality.

Research with humans

In the Netherlands, the Medical Research Involving Human Subjects Act (Wet Medisch wetenschappelijk onderzoek met mensen, WMO) came into force since 1998. All medical scientific research in which human participants are subjected to (medical) procedures or are required to follow rules of behavior, falls under the scope of this Act. All other research with humans (e.g. research with medical data or interviews) is not subject to the WMO.

Research subject to the WMO

Research subject to the WMO must be approved by an accredited independent committee of experts. The accreditation is granted by the Competent Authority. Both Amsterdam UMC locations VUmc AMC have an accredited medical research ethics committee (MREC; METc VUmc and METC AMC). Their job is to protect the rights of participants in medical research. Research proposals are only approved if the MREC establishes that the risks and burden for participants are in balance with the potential benefit for medical science or health care. Some types of research are not within the authority of MRECs and have to be approved by the Central Committee on Research Involving Human Subjects (CCMO). An example is research involving non-therapeutic interventions in children or incompetent persons.

Research not subject to the WMO

Research that is not subject to the WMO (nWMO), may concern prospective research using interviews and retrospective research using existing medical data. Amsterdam UMC in principle assesses all nWMO research according to certain predefined ethical and legal criteria. This assessment is performed by a dedicated review board under the responsibility of the MREC. Research proposals can be submitted to the executive board (dagelijks bestuur in Dutch) of the METc VUmc or METC AMC.

To set-up a biobank or to conduct research with material from a biobank, approval from the biobank review committee (TcB at VUmc and BTC at AMC) is needed. This committee focusses on evaluation of the legal and ethical aspects of the research.

Research with animals

Research involving laboratory animals is regulated by the Experiments on Animals Act (WOD). In compliance with the WOD, both Amsterdam UMC locations have an institutional license to perform experiments on animals. Moreover, for each project responsible researchers have to apply for a project license at the Central Authority for Scientific Procedures on Animals (CCD). Project permission is based on ethical assessment by an independent local committee of experts known as the Animal Ethics Committee (DEC).

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